Development and Validation of an Instrumented Ankle-foot Orthosis

TOPMED

Overview

Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling. TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Conditions

Foot Drop

Interventions

Instrumented OrthosisDEVICE

Gait analysis will be performed with the instrumented orthosis as well as the reference system.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria for Patients questionnaire: * Having foot drop Inclusion Criteria for Clinician questionnaire: * Being a clinician who treats foot drop patients Inclusion Criteria for Gait analysis: * Having foot drop Exclusion Criteria for Gait analysis: * Not being able to walk without a cane or a walker * Having lower extremity spasticity

Locations (1)

TOPMED

Québec, Canada

Outcomes

Primary Outcomes

Gait Temporal parameters

Gait Temporal parameters measured by the instrumented orthosis and the reference system, in seconds, these include the different phase durations(stride, stance and swing).

Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Heel strike angle

Heel strike angle measured by the instrumented orthosis and the reference system

Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Gait Spatial parameters

Gait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.

Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Gait speed

Gait speed measured by the instrumented orthosis and the reference system, in meters per second.

Time frame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session

Data from ClinicalTrials.gov

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